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Title: Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
Authors: BURZYKOWSKI, Tomasz
Piccart-Gebhart, Martine J.
Sledge, George
Carmichael, James
Lueck, Hans-Joachim
Mackey, John R.
Nabholtz, Jean-Marc
Paridaens, Robert
Biganzoli, Laura
Jassem, Jacek
Bontenbal, Marijke
Bonneterre, Jacques
Chan, Stephen
Basaran, Gul Atalay
Therasse, Patrick
Issue Date: 2008
Citation: JOURNAL OF CLINICAL ONCOLOGY, 26(12). p. 1987-1992
Abstract: Purpose Overall survival (OS) can be observed only after prolonged follow-up, and any potential effect of first-line therapies on OS may be confounded by the effects of subsequent therapy. We investigated whether tumor response, disease control, progression-free survival (PFS), or time to progression (TTP) could be considered a valid surrogate for OS to assess the benefits of first-line therapies for patients with metastatic breast cancer. Patients and Methods Individual patient data were collected on 3,953 patients in 11 randomized trials that compared an anthracycline (alone or in combination) with a taxane (alone or in combination with an anthracycline). Surrogacy was assessed through the correlation between the end points as well as through the correlation between the treatment effects on the end points. Results Tumor response (survival odds ratio [OR], 6.2; 95% CI, 5.3 to 7.0) and disease control (survival OR, 5.5; 95% CI, 4.8 to 6.3) were strongly associated with OS. PFS (rank correlation coefficient, 0.688; 95% CI, 0.686 to 0.690) and TTP (rank correlation coefficient, 0.682; 95% CI, 0.680 to 0.684) were moderately associated with OS. Response log ORs were strongly correlated with PFS log hazard ratios (linear coefficient [rho], 0.96; 95% CI, 0.73 to 1.19). Response and disease control log ORs and PFS and TTP log hazard ratios were poorly correlated with log hazard ratios for OS, but the confidence limits of rho were too wide to be informative. Conclusion No end point could be demonstrated as a good surrogate for OS in these trials. Tumor response may be an acceptable surrogate for PFS.
Notes: Hasselt Univ, Ctr Stat, B-3590 Diepenbeek, Belgium. Int Inst Drug Dev, Louvain, Belgium. Univ Hosp Gasthuisberg, B-3000 Louvain, Belgium. Inst Jules Bordet, B-1000 Brussels, Belgium. European Org Res Treatment Canc, Brussels, Belgium. Indiana Univ Purdue Univ, Indianapolis, IN 46202 USA. Astra Zeneca, Macclesfield, Cheshire, England. City Hosp Nottingham, Nottingham, England. Hannover Med Sch, D-30623 Hannover, Germany. Univ Alberta, Edmonton, AB, Canada. Breast Canc Res Inst Prandie, Valojoulx, France. Ctr Oscar Lambret, Lille, France. Hosp Prato, Padua, Italy. Med Univ, Gdansk, Poland. Univ Med Ctr, Erasmus MC, Rotterdam, Netherlands. Marmara Univ Hosp, Istanbul, Turkey.Burzykowski, T, Hasselt Univ, Ctr Stat, Bldg D, B-3590 Diepenbeek, Belgium.tomasz.burzykowski@uhasselt.be
URI: http://hdl.handle.net/1942/8258
DOI: 10.1200/JCO.2007.10.8407
ISI #: 000255054700015
ISSN: 0732-183X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2009
Appears in Collections: Research publications

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